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Trials, Registry Planned for Wound Care Device

By Alan, on March 27th, 2017

MRSA bacteria (National Institute of Allergy and Infectious Diseases)

27 March 2017. A company making products for healing wounds is studying the ways one of its dressings is used in the field, to better understand the product’s role in wound care. In this project, Organogenesis Inc. in Canton, Massachusetts is beginning two clinical studies and a patient registry to learn these details.

Organogenesis, a spin-off enterprise from MIT in the 1980s, develops bioactive wound care products that the company says are designed as much for regenerative medicine as emergency care. The product reviewed in this project is PuraPly AM, containing purified collagen derived from pigs, combined with an antimicrobial chemical. PuraPly is applied as a dressing to treat chronic wounds, such as venous and diabetic skin ulcers, as well as acute surgical and trauma wounds. PuraPly is cleared as a medical device by FDA, based on preclinical studies and case-study reports, but still lacking systematic clinical evidence.

Collagen is the most abundant protein in the body, found in bones and soft tissue, such skin and tendons. While the body makes collagen on its own, for wound care it provides a natural scaffold for tissue repair and regeneration. The antimicrobial ingredient in PuraPly is polyhexamethylene biguanide, or PHMB, added as a coating to the collagen to prevent formation of bacterial biofilms and further infections.

PHMB affects bacterial cells differently from mammalian cells, where the chemical enters bacterial cells and binds with its DNA, while with mammalian tissue, the chemical is kept out of the cells’ nuclei where DNA resides. As a result, says Organogenesis, PHMB does not have toxic effects on human cells as some silver-based topical antimicrobials, nor is it susceptible to an acquired resistance. The company cites lab tests where PuraPly reduced concentrations of a number of bacterial samples, including methicillin-resistant Staphylococcus aureus, or MRSA, a difficult “superbug” resistant to many antibiotics, and associated with infections contracted in health care facilities.

The new clinical trials conducted by Organogenesis aim to better understand the ways health care facilities are using PuraPly and their healing outcomes. The first trial at the Wound Healing Center at Winthrop-University Hospital in Mineola, New York is recruiting 100 adults with wounds treatable with PuraPly. The second trial, at Northwell Health in Lake Success, New York, is recruiting 40 participants, also with acute and chronic wounds treatable with PuraPly.

Participants in both trials will be tracked for 12 weeks to determine the extent of wound healing that occurs, with measurements of new tissue generation and wound closure, as well as bacterial formation in the wounds while they heal. Harold Brem, who heads Winthrop-University’s wound healing center says in an Organogenesis statement, “Up until now, we’ve seen encouraging case studies showing individual patient results following treatment with PuraPly AM,” but noting that the “prospective research program will provide wound care clinicians with important clinical data regarding how PuraPly AM is utilized in various wound types and the associated clinical outcomes.”

In addition, Organogenesis is starting a registry of 300 patients treated with PuraPly to track their experiences with the dressings. The initiative, known as Real-World Effectiveness Study of PuraPly AM On Wounds, or Respond Registry, will gather information on participants’ wound healing progress, as well as their experiences with pain, impact on quality of life, and any effects on economic outcomes.

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